F.D.A. Discusses Removal Of Most Severe Warning On Menopause Treatments

At a recent U.S. Food and Drug Administration (F.D.A.) panel, doctors argued for the removal of the black box warning on hormone treatments used to alleviate menopause symptoms.

The black box warning is the strongest warning the F.D.A. can place on a prescription drug’s label. The label usually notes serious risk of life-threatening conditions and/or death itself as side effects. It also denotes that the medicine should not be used to treat cardiovascular diseases or dementia.

The hormone treatments in question are used to alleviate menopause symptoms. The push is to remove the label from some of the drugs, not all.

The warning was placed on these medications in 2003 after a study by the Women’s Health Initiative suggested that hormone therapy pills containing both estrogen and progesterone can negatively impact health. The significant side effects include risk of breast cancer, blood clots, stroke and heart disease. Furthermore, the study was concluded a year early due to the harm it caused participants.

All panelists were asked to speak by Dr. Marty Makary, the F.D.A. commissioner. His stance, along with others on the panel, is in support of hormone therapy, according to The New York Times.

Marty and others argued the treatments come with benefits for those who start long-term use at the right time, according to the Times. The believed benefits include the prevention of cognitive decline, heart disease and some cancers. He says the W.H.I.‘s findings have caused a “breast cancer scare” which deterred women from the beneficial hormone treatment, the New York Times reported.

“Fifty-million-plus women have not been offered the incredible potential health benefits of hormone therapy,” he said at the panel.

Others raise questions about the validity of the argument. 

“This panel was set up by Dr. Makary to give him public reason to take the next step forward,” Cindy Pearson, who helped the W.H.I. obtain funding more than two decades ago, told the New York Times. “Using a mix of cherry-picked data, old citations and personal anecdotes to defend his conclusion that hormone therapy would be good for almost every woman who goes through menopause.”

She believes the panel did not adequately address both sides of the argument.

Monica Christmas, a gynecologist at the University of Chicago and associate medical director of The Menopause Society shared that The Menopause Society supports the removal of the black box warning label from vaginal estrogen products, according to Science News. However, removing the warning from pills, patches and other systemic estrogen treatments, which circulate in the blood through the whole body, is trickier. 

The dosage of these estrogen medicines are a big factor in the arguments presented. Additionally, vaginal estrogen medication, despite how they are administered to patients, all come with the same label because they all contain estrogen. Medications like patches and pills disperse the medication throughout the body as opposed to topical methods such as creams or gels.